D-0677-2026 Class II Ongoing
FDA drug recall D-0677-2026 was initiated by Padagis US LLC on June 23, 2026 and is designated Class II. Reason for recall: Subpotent Drug: Low out of specification assay results performed during long-term stability testing. The recall status is ongoing. Affected quantity: 180,936 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2026
- Initiation Date
- June 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180,936 tubes
Product Description
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Reason for Recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Distribution Pattern
USA Nationwide
Code Information
Lot #: 205060, Exp 09/30/2027